A clinical trial to study the safety of compound B09 in healthy males.

A randomized, double-blind, placebo- and active-controlled, cross over, single escalating dose study to assess the safety, tolerability and pharmacokinetics of compound B09 in healthy male subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001081

Enrollment

Registered

2010-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: B09: Single dose Control Intervention1: Baclofen: Single Dose Control Intervention2: Placebo: Single Dose

Eligibility

Inclusion criteria

Inclusion criteria: 1. Availability of subject for the entire study period and willingness to adhere to protocol requirements. 2. Healthy male subjects, 18 through 45 years of age, subjects having weight at least 50Kg and the subject?s body mass index (BMI) must be within 18.5 ? 25.0 (Kg/m2) (inclusive). 3. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21days prior to commencement of the study. 4. Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance. 5. Informed consent form given in written form

Exclusion criteria

Exclusion criteria: 1. History or presence of significant: -Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or any related compounds etc. -Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. -Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. -Clinically significant illness within 4 weeks before the start of the study. -Positive result to HIV, HCV and HBsAg. -Use of enzyme-modifying drugs in the previous 30 days before day 1 of this study. -Abnormal 12 lead ECG, X-ray. 2. Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study. 3. Participation in another clinical trial within the preceding 90 days of study starts. 4. Subjects who have: -Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg -Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. -Pulse rate below 60/min. or above 100/min.

Design outcomes

Primary

Measure	Time frame
Adverse events, vital signs, clinical laboratory tests, ECGTimepoint: Screening, Check-in, In-study, Check-out, Post-study	—

Secondary

Measure	Time frame
Pharmacokinetic parametersTimepoint: In-study	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Clinical.Trials@sparcmail.com912266455645

Outcome results